NCT06016647

Brief Summary

The percentage of loss time claims receiving Loss of Earnings benefits at 3 months has continued to rise amongst injured workers in Ontario despite the Workplace Safety and Insurance Board (WSIB) approach of "Better at Work". The primary health services to address loss time claims associated with musculoskeletal injuries include the evidenced-based programs of care, occupational health assessment program and musculoskeletal specialty programs, however, these are set to be revised and relaunched in Q1 2023. Across treatment protocols there are challenges that, at least in part, appear to contribute to the increasing percentage of workers on full loss of earnings at 3 months include (1) inconsistent early identification of workers who should be triaged to various health services and (2) reliable determination of the optimal timing of referral to the most targeted care to enable a safe and sustainable return to work. The investigators aim to develop and evaluate a predictive assessment model to triage workers to the best service within the first 8 weeks of their claim to increase the rate of early return to work, with the long-term goal that the triage protocol becomes part of a person-centric protocol that reduces the duration of work-related disability. The investigators will develop and evaluate an assessment protocol for injured workers that enter any of the musculoskeletal-specific WSIB programs of care, which have been consolidated into a single program as of 2023. This study will be a prospective inception cohort design using data collected from injured workers receiving WSIB musculoskeletal programs of care services at CBI Health clinics in Ontario Canada. Worker data will be collected at intake to the program of care service and again approximately four and eight weeks after intake (or earlier if a worker completes the program of care). The investigators will complete data analysis in three steps including descriptive and bivariate associations, Maximum Likelihood-based Latent Profile Analysis, and evaluation of results against successful work outcomes and secondary outcomes. Qualitative data will be mined for alternative indicators of recovery / non-recovery. The study recruitment goal is 300 - 350 workers with complete follow-up within a 2-year period.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

August 16, 2023

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Work status

    Full Return-to-Work, Return-to-Work with temporary restrictions, or redirected to other treatment options. With the Full RTW category serving as the reference against which the other outcomes will be considered.

    8 weeks

Secondary Outcomes (3)

  • Pain severity

    8 weeks

  • EuroQoL-5D (EQ5D-5L)

    8 weeks

  • Body diagram

    8 weeks

Other Outcomes (6)

  • MultiDimensional Symptom Index (MSI)

    8 weeks

  • A shortened 4-item version of The Self-Report version of the Leeds Assessment of Neuropathic Signs and Symptoms (S-LANSS).

    8 weeks

  • The Fremantle Body Awareness questionnaire - general version (FreBAQ-general)

    8 weeks

  • +3 more other outcomes

Interventions

Clinicians within this network provide care under a standardized framework that limits confounding from different interventions and the researchers will not manipulate treatment decisions.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is an observational prospective inception cohort using data collected from injured workers entering one of the CBIH programs of care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CBI Health

Multiple Locations, Ontario, Multiple Locations, Canada

RECRUITING

Related Publications (21)

  • Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.

    PMID: 15772908BACKGROUND
  • Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

    PMID: 8080219BACKGROUND
  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PMID: 21479777BACKGROUND
  • Tein JY, Coxe S, Cham H. Statistical Power to Detect the Correct Number of Classes in Latent Profile Analysis. Struct Equ Modeling. 2013 Oct 1;20(4):640-657. doi: 10.1080/10705511.2013.824781.

    PMID: 24489457BACKGROUND
  • Lee JY, Walton DM, Tremblay P, May C, Millard W, Elliott JM, MacDermid JC. Defining pain and interference recovery trajectories after acute non-catastrophic musculoskeletal trauma through growth mixture modeling. BMC Musculoskelet Disord. 2020 Sep 17;21(1):615. doi: 10.1186/s12891-020-03621-7.

    PMID: 32943021BACKGROUND
  • Modarresi S, Suh N, Walton DM, MacDermid JC. Depression affects the recovery trajectories of patients with distal radius fractures: A latent growth curve analysis. Musculoskelet Sci Pract. 2019 Oct;43:96-102. doi: 10.1016/j.msksp.2019.07.012. Epub 2019 Jul 27.

    PMID: 31374477BACKGROUND
  • Scheim AI, Bauer GR. The Intersectional Discrimination Index: Development and validation of measures of self-reported enacted and anticipated discrimination for intercategorical analysis. Soc Sci Med. 2019 Apr;226:225-235. doi: 10.1016/j.socscimed.2018.12.016. Epub 2019 Jan 21.

    PMID: 30674436BACKGROUND
  • Shi Q, Sinden K, MacDermid JC, Walton D, Grewal R. A systematic review of prognostic factors for return to work following work-related traumatic hand injury. J Hand Ther. 2014 Jan-Mar;27(1):55-62; quiz 62. doi: 10.1016/j.jht.2013.10.001. Epub 2013 Oct 21.

    PMID: 24268193BACKGROUND
  • Walton, D. et al. (2008) 'Prognostic Factors After Acute Whiplash Injury: Results Of A Meta-analysis', Journal of Orthopaedic & Sports Physical, 38(1), p. A23.

    BACKGROUND
  • Walton DM, Carroll LJ, Kasch H, Sterling M, Verhagen AP, Macdermid JC, Gross A, Santaguida PL, Carlesso L; ICON. An Overview of Systematic Reviews on Prognostic Factors in Neck Pain: Results from the International Collaboration on Neck Pain (ICON) Project. Open Orthop J. 2013 Sep 20;7:494-505. doi: 10.2174/1874325001307010494. eCollection 2013.

    PMID: 24115971BACKGROUND
  • Walton DM, Krebs D, Moulden D, Wade P, Levesque L, Elliott J, MacDermid JC. The Traumatic Injuries Distress Scale: A New Tool That Quantifies Distress and Has Predictive Validity With Patient-Reported Outcomes. J Orthop Sports Phys Ther. 2016 Oct;46(10):920-928. doi: 10.2519/jospt.2016.6594. Epub 2016 Sep 3.

    PMID: 27594662BACKGROUND
  • Walton DM, Mehta S, Seo W, MacDermid JC. Creation and validation of the 4-item BriefPCS-chronic through methodological triangulation. Health Qual Life Outcomes. 2020 May 7;18(1):124. doi: 10.1186/s12955-020-01346-8.

    PMID: 32381020BACKGROUND
  • Walton DM, Elliott JM, Lee J, Fakhereddin M, Seo W. Identification of clinically-useful cut scores of the Traumatic Injuries Distress Scale (TIDS) for predicting rate of recovery following musculoskeletal trauma. PLoS One. 2021 Mar 23;16(3):e0248745. doi: 10.1371/journal.pone.0248745. eCollection 2021.

    PMID: 33755664BACKGROUND
  • Walton DM, Elliott JM. An Integrated Model of Chronic Whiplash-Associated Disorder. J Orthop Sports Phys Ther. 2017 Jul;47(7):462-471. doi: 10.2519/jospt.2017.7455. Epub 2017 Jun 16.

    PMID: 28622487BACKGROUND
  • Walton DM, Elliott JM. A new clinical model for facilitating the development of pattern recognition skills in clinical pain assessment. Musculoskelet Sci Pract. 2018 Aug;36:17-24. doi: 10.1016/j.msksp.2018.03.006. Epub 2018 Apr 9.

    PMID: 29669311BACKGROUND
  • Walton DM, Marsh J. Reliability, Discriminative, and Prognostic Validity of the Multidimensional Symptom Index in Musculoskeletal Trauma. Clin J Pain. 2020 Sep;36(9):700-706. doi: 10.1097/AJP.0000000000000856.

    PMID: 32520818BACKGROUND
  • Walton DM, Phares P. The potential and perils of prognosticating persistent post-traumatic problems from a postpositivist perspective. Spine J. 2018 Aug;18(8):1483-1488. doi: 10.1016/j.spinee.2018.01.015. Epub 2018 Jan 31.

    PMID: 29355787BACKGROUND
  • Walton DM, Beattie T, Putos J, MacDermid JC. A Rasch analysis of the Brief Pain Inventory Interference subscale reveals three dimensions and an age bias. J Clin Epidemiol. 2016 Jun;74:218-26. doi: 10.1016/j.jclinepi.2015.10.022. Epub 2016 Jan 6.

    PMID: 26769256BACKGROUND
  • Walton DM, Putos J, Beattie T, MacDermid JC. Confirmatory factor analysis of 2 versions of the Brief Pain Inventory in an ambulatory population indicates that sleep interference should be interpreted separately. Scand J Pain. 2016 Jul;12:110-116. doi: 10.1016/j.sjpain.2016.05.002. Epub 2016 May 25.

    PMID: 28850482BACKGROUND
  • Walton DM, Elliott JM, Salim S, Al-Nasri I. A reconceptualization of the pain numeric rating scale: Anchors and clinically important differences. J Hand Ther. 2018 Apr-Jun;31(2):179-183. doi: 10.1016/j.jht.2017.12.008. Epub 2018 Feb 9. No abstract available.

    PMID: 29433765BACKGROUND
  • Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.

    PMID: 27327235BACKGROUND

MeSH Terms

Conditions

Low Back PainNeck PainArm Injuries

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • David Walton, PhD

    CANSpine Lab, School of Physical Therapy, Western University, Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Walton, PhD

CONTACT

Aliyu Lawan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, School of Physical Therapy (cross-appt. Dept. of Psychiatry)

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 30, 2023

Study Start

August 31, 2023

Primary Completion

April 30, 2025

Study Completion

August 30, 2025

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Upon study completion, we will pursue options for making the de-identified data open-access through engagement with the REB around safe and ethical data sharing.

Shared Documents
ANALYTIC CODE
Time Frame
Upon study completion
Access Criteria
Open access and administrative database.

Locations